UMIN-CTR Clinical Trial

Basic information
Public title	Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Acronym	Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Scientific Title	Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Scientific Title:Acronym	Effects of outpatient supervised exercise therapy on physical and renal function in patients with peripheral arterial disease of the lower extremities
Region	Japan

Condition
Condition	peripheral arterial disease of the lower extremities
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the impact of a comprehensive outpatient cardiovascular disease rehabilitation program intervention after endovascular treatment for cases of peripheral arterial disease of the lower extremities on renal function, physical activity and gait function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical function assessment : 6-Minute Walk Test, grip of hand, knee extension strength, pain-free walking distance, claudication onset time, maximum walking distance, peak walking time, Walking Impairment Questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	supervised exercise therapy
Interventions/Control_2	conventional therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients diagnosed with Fontain Class II peripheral artery disease of the lower extremities and admitted to Aomori Kyoritsu Hospital for endovascular treatment (2) Patients who had been making regular outpatient visits at the same facility for at least 3 months prior to endovascular treatment (3) Patients who regularly visit the same facility as an outpatient for more than 3 months after discharge from the hospital. (4) Patients who have been provided with an explanation of the research and whose written consent has been obtained from them.
Key exclusion criteria	(1) Patients who are not able to walk independently (2) Patients with critical limb ischemia (3) Dialysis patients (4) Patients with a diagnosis of dementia prior to discharge (5) Patients with untreated coronary artery disease (6) Patients with grade III or greater heart failure according to NYHA cardiac function classification (7) Patients with severe chronic obstructive pulmonary disease (8) Patients with poorly controlled diabetes (9) Patients with outflow tract stenosis due to aortic stenosis or hypertrophic cardiomyopathy or other diseases. (10) Patients with advanced atrioventricular block who have not had a pacemaker implanted. (11) Other patients who are deemed by the attending physician to be an undesirable subject for this study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name MASAHIRO Middle name Last name KOHZUKI
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Internal Medicine & Rehabilitation Science Disability Science
Zip code	980-8574
Address	1-1, Seiryo-cho, Aoba-ku Sendai
TEL	022-717-7351
Email	kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person	1st name TAKAYUKI Middle name Last name NAITO
Organization	Aomori Kyoritsu Hospital
Division name	Internal Medicine
Zip code	030-0847
Address	2-1-10 Higashi-Ohno, Aomori City
TEL	017-762-5500
Homepage URL
Email	takatakanaitou@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University
Address	1-1, Seiryo-cho, Aoba-ku Sendai
Tel	022-717-7351
Email	takatakanaitou@med.tohoku.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	あおもり協立病院（青森県）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 20 Day
Last modified on	2020 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047707

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.